Ignite Creation Date:
2024-05-05 @ 9:20 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00860847
Status:
COMPLETED
Last Update Posted:
2015-03-12
First Post:
2009-03-11
Brief Title:
Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease FAITH
Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Organization:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Overview
Official Title:
Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease FAITH
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Statement of Problem
According to the National Fire Protection Association NFPA 437 of all firefighters that died on the job experienced sudden cardiac death The job also affords an incredible amount of stress Cholesterol therapy has been well demonstrated to reduce coronary plaque progression However is certainly not the only factor in evaluating for progression of coronary artery disease CAD and other factors must play a role Garlic therapy has been shown to retard atherosclerosis independently
2 Hypothesis and Specific Aims The hypothesis of this proposal is In comparison to the placebo group Aged Garlic Extract AGE therapy Coenzyme Q10 CoQ10 will be effective in slowing progression of coronary artery calcification CAC in firefighters with established atherosclerosis independent of baseline blood pressure statin use or other cardiovascular risk factors
Specific Aims
1 Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract CoQ10 or placebo
2 Compare whether degree of change in atherosclerotic coronary artery plaque burden will change at a different rate under the influence of Aged Garlic Extract CoQ10 compared to placebo treatment
3 Compare whether Aged Garlic Extract CoQ10 therapy induces changes in baseline values including biological and biochemical parameters such as LDL cholesterol homocysteine C-reactive protein CRP and endothelial function
According to the National Fire Protection Association NFPA 437 of all firefighters that died on the job experienced sudden cardiac death The job also affords an incredible amount of stress Cholesterol therapy has been well demonstrated to reduce coronary plaque progression However is certainly not the only factor in evaluating for progression of coronary artery disease CAD and other factors must play a role Garlic therapy has been shown to retard atherosclerosis independently
2 Hypothesis and Specific Aims The hypothesis of this proposal is In comparison to the placebo group Aged Garlic Extract AGE therapy Coenzyme Q10 CoQ10 will be effective in slowing progression of coronary artery calcification CAC in firefighters with established atherosclerosis independent of baseline blood pressure statin use or other cardiovascular risk factors
Specific Aims
1 Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract CoQ10 or placebo
2 Compare whether degree of change in atherosclerotic coronary artery plaque burden will change at a different rate under the influence of Aged Garlic Extract CoQ10 compared to placebo treatment
3 Compare whether Aged Garlic Extract CoQ10 therapy induces changes in baseline values including biological and biochemical parameters such as LDL cholesterol homocysteine C-reactive protein CRP and endothelial function
Detailed Description:
Inclusion Criteria
Calcium scan with Agatston score 20
Age 35-84 years
Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
Subjects should be stable on their concomitant medications for at least 12 weeks prior to randomization
Subjects who agree to refrain from supplemental garlic or significant dietary garlic
Exclusion Criteria
A contraindication to Aged Garlic Extract therapy including known hypersensitivity to drug
Any unstable medical psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subjects ability to complete the study or precludes the subjects participation in the study
Weight in excess of 325 pounds
Bleeding disorder
History of myocardial infarction stroke or life-threatening arrhythmia within the prior six months
Resting hypotension a resting systolic blood pressure of 90 mm Hg or hypertension a resting blood pressure 170 mm Hg or a resting diastolic blood pressure of 110 mm Hg
NYHA Class III or IV heart failure
History of malignancy within the last 5 years other than skin cancer or evidence of active cancer which would require concomitant cancer chemotherapy
Serum creatinine 14 mgdl
Triglycerides 400 at visit 1
Diabetic subjects with HbA1c 12
Drug or alcohol abuse or current intake of more than 14 standard drinks per week
Concurrent enrollment in another placebo-controlled trial
Presence of metal clips ie bypass patients or intracoronary stenting that preclude accurate measure of coronary calcification
Partial ileal bypass or known gastrointestinal disease limiting drug absorption
Current intake of garlic supplement or other prohibited drug Appendix B
Current tobacco use
Current use of anticoagulants except for antiplatelet agents
Chronic renal failure
Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
Outcome Measures Primary - Rate of change in total coronary calcium scores by CT The Agatston score was calculated by multiplying the lesion area mm2 by a density factor The density was measured in Hounsfield units and score of 1 for 130-199 HU 2 for 200-299 HU 3 for 300-399 HU and 4 for 400 HU and greater
Secondary Change in blood values and endothelial function over 6 and 12 months
1 Plasma lipids total plasma cholesterol and triglycerides LDL-Cholesterol HDL-Cholesterol and VLDL-Cholesterol determined by the precipitation method
2 Endothelial markers and inflammation C-reactive protein and Homocysteine as well as GSH
Calcium scan with Agatston score 20
Age 35-84 years
Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
Subjects should be stable on their concomitant medications for at least 12 weeks prior to randomization
Subjects who agree to refrain from supplemental garlic or significant dietary garlic
Exclusion Criteria
A contraindication to Aged Garlic Extract therapy including known hypersensitivity to drug
Any unstable medical psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subjects ability to complete the study or precludes the subjects participation in the study
Weight in excess of 325 pounds
Bleeding disorder
History of myocardial infarction stroke or life-threatening arrhythmia within the prior six months
Resting hypotension a resting systolic blood pressure of 90 mm Hg or hypertension a resting blood pressure 170 mm Hg or a resting diastolic blood pressure of 110 mm Hg
NYHA Class III or IV heart failure
History of malignancy within the last 5 years other than skin cancer or evidence of active cancer which would require concomitant cancer chemotherapy
Serum creatinine 14 mgdl
Triglycerides 400 at visit 1
Diabetic subjects with HbA1c 12
Drug or alcohol abuse or current intake of more than 14 standard drinks per week
Concurrent enrollment in another placebo-controlled trial
Presence of metal clips ie bypass patients or intracoronary stenting that preclude accurate measure of coronary calcification
Partial ileal bypass or known gastrointestinal disease limiting drug absorption
Current intake of garlic supplement or other prohibited drug Appendix B
Current tobacco use
Current use of anticoagulants except for antiplatelet agents
Chronic renal failure
Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
Outcome Measures Primary - Rate of change in total coronary calcium scores by CT The Agatston score was calculated by multiplying the lesion area mm2 by a density factor The density was measured in Hounsfield units and score of 1 for 130-199 HU 2 for 200-299 HU 3 for 300-399 HU and 4 for 400 HU and greater
Secondary Change in blood values and endothelial function over 6 and 12 months
1 Plasma lipids total plasma cholesterol and triglycerides LDL-Cholesterol HDL-Cholesterol and VLDL-Cholesterol determined by the precipitation method
2 Endothelial markers and inflammation C-reactive protein and Homocysteine as well as GSH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None